Trial · NCT00189488
Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation
NCT00189488, Phase 2, Completed, Swedish Orphan Biovitrum; results first posted 2014-09-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation. Trials, record NCT00189488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00189488
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation
- NCT number
- NCT00189488
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 155 participants, actual
- Lead sponsor
- Swedish Orphan Biovitrum
- Conditions
- Graft Versus Host Disease, Hematologic Malignancies
- Interventions
- Palifermin, Placebo, Conditioning Regimen, Allogeneic stem cell transplant, Methotrexate
- First posted
- 2005-09-19
- Last updated
- 2014-09-15
- Results first posted
- 2014-09-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD) | From transplant (Day 0) until Day 100 | GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100. Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors. Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus. Grade 4 GVHD = skin involvement with bullous formation or total bilirubin \> 15.0 mg/dL. |
| Secondary | Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD) | From transplant (Day 0) until Day 100 | GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100. Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors. Grade 2 GVHD = \> 50% skin involvement or total bilirubin 2.0 - 3.0 mg/dL or 500 - 999 mL/day diarrhea, or persistent nausea with histologic evidence. Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus. Grade 4 GVHD = skin involvement with bullous formation or total bilirubin \> 15.0 mg/dL. |
| Secondary | Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration | Day 11 | Low dose methotrexate is widely used in regimens to prophylax against acute GVHD. Methotrexate was administered on days 1, 3, 6 and 11 (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2, respectively. |
| Secondary | Number of Participants With Severe (Grade 3 or 4) Oral Mucositis | From transplant (Day 0) until Day 100 | Oral cavity assessments were performed by a trained assessor using the World Health Organization (WHO) oral toxicity scale. Daily oral mucositis assessments were performed: * while participants were hospitalized, including the day of discharge (maximum until day 28); * after discharge until the oral mucositis grade returns to a WHO grade ≤ 2. The WHO oral toxicity criteria are: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. |
| Secondary | Duration of Severe Oral Mucositis (WHO Grade 3 and 4) | From transplant (Day 0) until Day 100 | The duration of severe oral mucositis was calculated as the number of days from the onset of severe mucositis (first time a WHO grade of 3 or 4 was observed) to the last day when severe mucositis was observed. If oral mucositis assessments were recorded as missed visits immediately prior to or immediately after severe mucositis was recorded, the missed visits were considered to be severe oral mucositis. |
| Secondary | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | From transplant (Day 0) until Day 100 | Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia. |
| Secondary | Duration of Hospitalization | From transplant (Day 0) until Day 100 | Duration of hospitalization was defined as the number of days a participant stayed in hospital (hospitalized) during the period starting from the day of the transplant (Day 0) to the 100th day following the transplant. |
| Secondary | Area Under the Curve (AUC) of Mouth and Throat Soreness Score | The first day of study drug administration through Day 28. | The modified Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The modified OMDQ was completed once daily beginning with the first day of study drug administration through day 28. The area under the curve of mouth and throat soreness score was assessed from the question "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD) | From transplant (Day 0) until Day 100 | Primary Analysis Set (consisting of all randomized participants) with GVHD assessments. | Participants | NUMBER |
| PRIMARY | Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD) | From transplant (Day 0) until Day 100 | Primary Analysis Set (consisting of all randomized participants) with GVHD assessments. Efficacy analyses were according to randomized treatment assignment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration | Day 11 | Primary Analysis Set | Participants | NUMBER |
| SECONDARY | Number of Participants With Severe (Grade 3 or 4) Oral Mucositis | From transplant (Day 0) until Day 100 | Primary Analysis Set | Participants | NUMBER |
| SECONDARY | Duration of Severe Oral Mucositis (WHO Grade 3 and 4) | From transplant (Day 0) until Day 100 | Primary Analysis Set | days | MEAN |
| SECONDARY | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | From transplant (Day 0) until Day 100 | Primary Analysis Set | Participants | NUMBER |
| SECONDARY | Duration of Hospitalization | From transplant (Day 0) until Day 100 | Primary analysis set | days | MEAN |
| SECONDARY | Area Under the Curve (AUC) of Mouth and Throat Soreness Score | The first day of study drug administration through Day 28. | Primary analysis set | MTS score * days | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD) | Placebo | Yes | 29 | Participants | |
| Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD) | Palifermin | Yes | 43 | Participants | |
| Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD) | Placebo | No | 43 | Participants | |
| Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD) | Palifermin | No | 31 | Participants | |
| Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD) | Placebo | Yes | 12 | Participants | |
| Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD) | Palifermin | Yes | 12 | Participants | |
| Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD) | Placebo | No | 60 | Participants | |
| Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD) | Palifermin | No | 62 | Participants | |
| Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration | Placebo | Yes | 56 | Participants | |
| Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration | Palifermin | Yes | 60 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 78 | |
| Overall Study | STARTED | Palifermin | 77 | |
| Overall Study | Received Palifermin/Placebo | Placebo | 75 | |
| Overall Study | Received Palifermin/Placebo | Palifermin | 76 | |
| Overall Study | COMPLETED | Placebo | 63 | |
| Overall Study | COMPLETED | Palifermin | 55 | |
| Overall Study | NOT COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Palifermin | 22 |
Source ClinicalTrials.gov
Adverse events534
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 14 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | Palifermin | 13 | 78 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo | 24 | 73 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Palifermin | 24 | 78 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 4 | 73 | |
| other | Neutropenia | Blood and lymphatic system disorders | Palifermin | 2 | 78 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Placebo | 5 | 73 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Palifermin | 7 | 78 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 14 | 73 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Palifermin | 13 | 78 |
1 to 10 of 534Source ClinicalTrials.gov
See all 534 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Palifermin | ||
| Total, other adverse events | Placebo | 71 | 73 |
| Total, other adverse events | Palifermin | 77 | 78 |
| Total, serious adverse events | Placebo | 40 | 73 |
| Total, serious adverse events | Palifermin | 50 | 78 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Palifermin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00189488
GET https://conductscience.org/api/trials/v1/NCT00189488/results?page=2